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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00866697




Registration number
NCT00866697
Ethics application status
Date submitted
19/03/2009
Date registered
19/03/2009
Date last updated
24/10/2018

Titles & IDs
Public title
Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Scientific title
A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Secondary ID [1] 0 0
2008-004672-50
Secondary ID [2] 0 0
110655
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pazopanib
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - matched placebo tablet administered orally once daily for up to 24 months

Experimental: Pazopanib - Pazopanib tablet administered orally at 800 mg once daily for up to 24 months


Treatment: Drugs: Pazopanib
Pazopanib 800 mg tablet daily for 104 weeks (24 months)

Treatment: Drugs: Placebo
Matching placebo 800 mg tablet daily, for 104 weeks (24 months).

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Investigator-assessed Progression-free Survival (PFS) - PFS is the interval between the date of randomization and the date of progression, defined by Response Evaluation Criteria in Solid Tumors (RECIST), or death due to any cause. Per RECIST, for target lesions (TLs), disease progression (PD) is defined as >=20% increase in the sum of the longest diameters (LD) of TLs, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesions. For non-target lesions (NTLs), PD is defined as the appearance of >=1 new lesions and/or unequivocal progression of existing NTLs. Participants (par.) who did not progress/die were censored at the date of last adequate assessment (LAA). Par. who started a new anti-cancer therapy (ACT) prior to radiological progression/death were censored at the date of LAA prior to the new ACT. Par. who progressed/died after an extended period (>=12 months) without adequate assessment (AA) were censored at the date of their last visit with AA prior to progression/death.
Timepoint [1] 0 0
From the date of randomization until the date of progression or death due to any cause (median time of follow-up was 17.9 months for pazopanib and 12.3 months for placebo)
Secondary outcome [1] 0 0
Overall Survival - Median - Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.
Timepoint [1] 0 0
From the date of randomization until the date of death due to any cause up to approximately 95 months
Secondary outcome [2] 0 0
Overall Survival - Hazard Ratio - Overall surival is defined as the interval between the date of randomization and the date of death due to any cause. For participants who did not die, the time to death was censored at the time of last contact.
Timepoint [2] 0 0
From the date of randomization until the date of death due to any cause up to approximately 95 months
Secondary outcome [3] 0 0
Progression-free Survival Per Gynecologic Cancer Intergroup (GCIG) Criteria - Progression-free survival by GCIG criteria is defined as the time from the date of randomization to the earliest date of disease progression per GCIG criteria or death due to any cause. Progression is defined according to RECIST but can also be based upon serum CA-125. Progression or recurrence based on serum CA-125 levels are defined on the basis of a progressive serial elevation of serum CA-125, according to the following criteria: (1) participants (par.) with elevated CA-125 pretreatment and normalization of CA-125 must show evidence of CA-125 >=2x the upper normal limit (UNL) on two occasions at least one week apart or; (2) par. with elevated CA-125 pretreatment, which never normalizes, must show evidence of CA-125 >=2x the nadir value on two occasions at least one week apart or; (3) par. with CA-125 in the normal range pretreatment must show evidence of CA-125 >=2x the UNL on two occasions at least one week apart.
Timepoint [3] 0 0
From the date of randomization until the date of progression per GCIG criteria or death due to any cause (median time of follow-up was 16.8 months for pazopanib and 11.9 months for placebo)
Secondary outcome [4] 0 0
3-year Progression-free Survival - 3-year progression-free survival is defined as the percentage of participants who are progression-free at 3 years from randomization. Progression-free survival is defined as the time from the date of randomization to the earliest date of disease progression (defined by RECIST) or death due to any cause. Per RECIST, for target lesions, disease progression (PD) is defined as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as a reference, the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For non-target lesions, PD is defined as the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Timepoint [4] 0 0
Up to 3 years after randomization
Secondary outcome [5] 0 0
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25 - The EORTC QLQ-C30 is a self-reported, 30-item cancer-specific instrument that assesses 15 domains: 5 functional scales (physical, role, emotional, cognitive, and social functioning), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health status, or quality of life. Global health status is assessed using a 7-item Likert scale, ranging from 1 to 7 ("poor" to "excellent"). Participants were asked to respond to the following questions using the 7-item Likert scale: "How would you rate your overall health during the past week"; "How would you rate your overall quality of life during the past week?" Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures analysis of covariance (ANCOVA).
Timepoint [5] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [6] 0 0
Change From Baseline in QLQ-OV-28 Module Attitude to Disease/Treatment Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25 - The OV (ovarian)-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses attitude to disease/treatment functional symptoms, among others. Participants were asked to indicate the extent to which they experienced attention to disease/treatment functional problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: How much has your disease been a burden to you?; How much has your treatment been a burden to you?; Were you worried about your future health? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Timepoint [6] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [7] 0 0
Change From Baseline in QLQ-OV-28 Module Body Image Functional Score on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25 - The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses body image symptoms, among others. Participants were asked to indicate the extent to which they experienced body image problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you felt physically less attractive as a result of your disease or treatment?; Have you been dissatisfied with your body? Data are transformed to a scale ranging from 0 to 100. Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Timepoint [7] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [8] 0 0
Change From Baseline in QLQ-OV-28 Module Peripheral Neuropathy (PN) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25 - The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses peripheral neuropathy symptoms, among others. Participants were asked to indicate the extent to which they experienced peripheral neuropathy symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have tingling hands or feet?; Have you had numbness in your fingers or toes?; Have you felt weak in your arms or legs? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Timepoint [8] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [9] 0 0
Change From Baseline in QLQ-OV-28 Module Abdominal (AB)/Gastrointestinal (GI) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25 - The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses AB/GI symptoms, among others. Participants were asked to indicate the extent to which they experienced AB/GI symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have abdominal pain?; Did you have a bloated feeling in your abdomen/stomach?; Did you have problems with your clothes feeling too tight?; Did you experience any change in bowel habit as a result of your disease or treatment?; Were you troubled by passing wind/gas/flatulence?; Have you felt full too quickly after beginning to eat?; Have you had indigestion/heartburn? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Timepoint [9] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [10] 0 0
Change From Baseline in QLQ-OV-28 Module Hormonal/Menopausal Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25 - The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses hormonal/menopausal symptoms, among others. Participants were asked to indicate the extent to which they experienced hormonal/menopausal symptoms or problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Did you have hot flashes?; Did you have night sweats? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Timepoint [10] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [11] 0 0
Change From Baseline in QLQ-OV-28 Module Sexuality Functional on Day 1 of Week 13 and Months 7, 10, 13, 16, and 25 - The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses sexual functioning symptoms, among others. Participants were asked to indicate the extent to which they experienced sexual functioning problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: To what extent were you interested in sex?; To what extent were you sexually active?; If sexually active, to what extent was sex enjoyable for you?; If sexually active, did you have a dry vagina during sexual activity? Higher scores represent better functioning (better quality of life). Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).
Timepoint [11] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [12] 0 0
Change From Baseline in QLQ-OV-28 Module Other Chemotherapy Side Effects (SE) Symptoms Score at Week 13 and Months 7, 10, 13, 16, and 25 - The OV-28 module is a 28-item addition to the EORTC QLQ-C30 that focuses on issues specific to ovarian cancer. It assesses other chemotherapy SE symptoms, among others. Participants were asked to indicate the extent to which they experienced other chemotherapy SE symptoms/problems in the week prior to assessment. Participants responded on a scale of 1-4 (1=not at all, 2=a little, 3=quite a bit, 4=very much) to the following questions: Have you lost any hair?; If yes, were you upset by the loss of your hair?; Did food/drink taste different from usual?; Did you have aches or pains in your muscles or joints?; Did you have problems with hearing?; Did you urinate frequently?; Have you had skin problems (e.g., itchy, dry)? Data are transformed to a scale from 0 to 100. Lower scores represent better health (fewer symptoms) for symptom scales. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA. Data were not analyzed due to low compliance (<50% at Baseline).
Timepoint [12] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [13] 0 0
Change From Baseline in the EuroQOL EQ-5D (Five Dimensions) Thermometer Score at Week 13 and Months 7, 10, 13, 16, and 25 - The EuroQol (EQ-5D) questionnaire is a 2-page, generic, preference-based quality of life measure comprised of a 5-item health status measure and a visual analogue scale (VAS) and is used to generate two scores: the utility score and the thermometer score The thermometer score is based on a vertical VAS. The VAS is designed like a thermometer scale on which the best health state the participant can imagine is referenced at 100, and the worst health state the participant can imagine is marked by 0. Based on how good or bad the current health state is, the participant is asked to draw a line across the thermometer scale. For example, a line drawn across 46 on the scale of 0 to 100 would be coded 46. A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Timepoint [13] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [14] 0 0
Change From Baseline in the EQ-5D (Five Dimensions) Utility Score at Week 13 and Months 7, 10, 13, 16, and 25 - The EQ-5D utility score captures health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety and/or depression. Participants indicated the level of perceived problems in each of the five dimensions on three levels: 1, no problems; 2, some problems; 3, an extreme problem. Unique health states were defined by combining response levels from each of the five dimensions. For example, state 11111 indicates no problem on any of the five dimensions, whereas state 11223 indicates no problems with mobility or self-care; some problems with performing usual activities, moderate pain/discomfort; and extreme anxiety/depression. Responses are typically converted into health utilities or valuations on a scale ranging from 0 (worst health) to 1 (perfect health). A negative adjusted mean change from Baseline represents a worsening of quality of life. Mean changes from Baseline were calculated via mixed model-repeated measures ANCOVA.
Timepoint [14] 0 0
Baseline; Week 13; Months 7, 10, 13, 16, and 25
Secondary outcome [15] 0 0
Number of Participants With the Indicated Grade 2, 3, and 4 On-therapy Adverse Events Occurring in >=10% of Participants in Either Treatment Arm - An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death.
Timepoint [15] 0 0
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Secondary outcome [16] 0 0
Number of Participants With the Indicated On-therapy Hematology Grade Shifts From Baseline Grade - Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0. WBC=White blood cell.
Timepoint [16] 0 0
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Secondary outcome [17] 0 0
Number of Participants With the Indicated On-therapy Chemistry Grade Shifts From Baseline Grade - Hematology toxicities were graded according to the Common Terminiology Criteria for Adverse Events (CTCAE), Version 4.0. Grade refers to the severity of the toxicity. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life threatening; Grade 5, death. Participants with a missing Baseline grade were assumed to have a Baseline grade of 0.
Timepoint [17] 0 0
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)
Secondary outcome [18] 0 0
Number of Participants With the Indicated Treatment-emergent Thyroid-stimulating Hormone (TSH) Elevations Above 5 Million Units Per Liter (MU/L) - Participants were assessed for thyroid function abnormalities. Clinical hypothyroidism is defined as 5 <TSH <=10 MU/L and T4 <lower limit of normal (LLN).
Timepoint [18] 0 0
From the date of the first dose of study drug to the date of the last dose plus 28 days (average of 9.8 months for pazopanib and 12.6 months for placebo)

Eligibility
Key inclusion criteria
- written informed consent

- At least 18 years old.

- Histologically confirmed, FIGO stage II-IV epithelial ovarian, fallopian tube or
primary peritoneal carcinoma that was treated with surgical debulking and at least
five cycles of platinum-taxane doublet chemotherapy.

- Study randomization at least 3 weeks and not more than 12 weeks from the date of the
last chemotherapy dose, and all major toxicities from the previous chemotherapy must
have resolved.

- No evidence of disease progression

- ECOG status of 0 or 2

- Able to swallow and retain oral medication.

- Adequate hematologic, hepatic, and renal system function as follows:

Hematologic

- Absolute neutrophil count (ANC) at least 1.5 X 10^9/L

- Hemoglobin at least 9 g/dL (or 5.59 mmol/L)

- Platelets at least 100 X 10^9/L

- Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN

- Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic

- Total bilirubin up to 1.5 X ULN

- AST and ALT up to 2.5 X ULN Renal

- Serum creatinine up to 1.5 mg/dL

Or, if greater than 1.5 mg/dL:

Calculated creatinine clearance at least 50 mL/min Urine Protein

- Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram
determined by 24- hour urine protein analysis.

- Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR
childbearing potential, and agrees to use adequate contraception.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Either (a) bulky disease, or (b) any residual disease which in the opinion of the
investigator will need imminent second-line therapy

- Synchronous primary endometrial carcinoma, or a past history of primary endometrial
carcinoma, are excluded unless certain conditions are met.

- Clinically significant gastrointestinal abnormalities

- Prolongation of corrected QT interval (QTc) > 480 msecs

- History of any one or more cardiovascular conditions within the past 6 months prior to
randomization

- Cardiac angioplasty or stenting

- Myocardial infarction

- Unstable angina

- Symptomatic peripheral vascular disease

- Class III or IV congestive heart failure

- Poorly controlled hypertension

- History of cerebrovascular accident (including transient ischemic attacks), pulmonary
embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to
randomization

- Major surgery (including interval debulking) or trauma within 28 days, or minor
surgical procedures within 7 days, prior to randomization, or has any non-healing
wound, fracture, or ulcer.

- Evidence of active bleeding or bleeding diathesis.

- Hemoptysis within 6 weeks prior to randomization.

- Endobronchial metastases.

- Serious and/or unstable pre-existing medical (e.g., uncontrolled infection),
psychiatric, or other condition that could interfere with subject's safety, provision
of informed consent, or compliance to study procedures.

- Investigational or anti-VEGF anticancer therapy prior to study randomization.

- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs
chemically related to pazopanib

- Invasive malignancies that showed activity of disease within 5 years prior to
randomization

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Camperdown
Recruitment hospital [2] 0 0
Novartis Investigative Site - Randwick
Recruitment hospital [3] 0 0
Novartis Investigative Site - Waratah
Recruitment hospital [4] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [5] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [6] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [7] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [8] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [9] 0 0
Novartis Investigative Site - Wodonga
Recruitment hospital [10] 0 0
Novartis Investigative Site - Nedlands
Recruitment hospital [11] 0 0
Novartis Investigative Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4029 - Herston
Recruitment postcode(s) [5] 0 0
4101 - South Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3052 - Parkville
Recruitment postcode(s) [9] 0 0
3690 - Wodonga
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment postcode(s) [11] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia
Country [6] 0 0
Austria
State/province [6] 0 0
Graz
Country [7] 0 0
Austria
State/province [7] 0 0
Innsbruck
Country [8] 0 0
Austria
State/province [8] 0 0
Klagenfurt Am Woerthersee
Country [9] 0 0
Austria
State/province [9] 0 0
Korneuburg
Country [10] 0 0
Austria
State/province [10] 0 0
Linz
Country [11] 0 0
Austria
State/province [11] 0 0
Wien
Country [12] 0 0
Belgium
State/province [12] 0 0
Gent
Country [13] 0 0
Belgium
State/province [13] 0 0
Kortrijk
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Libramont
Country [16] 0 0
Belgium
State/province [16] 0 0
Namur
Country [17] 0 0
Belgium
State/province [17] 0 0
Oostende
Country [18] 0 0
China
State/province [18] 0 0
Guangdong
Country [19] 0 0
China
State/province [19] 0 0
Jiangsu
Country [20] 0 0
China
State/province [20] 0 0
Liaoning
Country [21] 0 0
China
State/province [21] 0 0
Shandong
Country [22] 0 0
China
State/province [22] 0 0
Zhejiang
Country [23] 0 0
China
State/province [23] 0 0
Beijing
Country [24] 0 0
China
State/province [24] 0 0
Shanghai
Country [25] 0 0
China
State/province [25] 0 0
Tianjin
Country [26] 0 0
Denmark
State/province [26] 0 0
Aalborg
Country [27] 0 0
Denmark
State/province [27] 0 0
Herlev
Country [28] 0 0
Denmark
State/province [28] 0 0
Koebenhavn Oe
Country [29] 0 0
France
State/province [29] 0 0
ANGERS Cedex 2
Country [30] 0 0
France
State/province [30] 0 0
Besancon Cedex
Country [31] 0 0
France
State/province [31] 0 0
Bordeaux
Country [32] 0 0
France
State/province [32] 0 0
Bourg en Bresse Cedex
Country [33] 0 0
France
State/province [33] 0 0
Brest Cedex
Country [34] 0 0
France
State/province [34] 0 0
Caen Cedex 05
Country [35] 0 0
France
State/province [35] 0 0
Clermont-Ferrand cedex
Country [36] 0 0
France
State/province [36] 0 0
Colmar Cedex
Country [37] 0 0
France
State/province [37] 0 0
Grenoble Cedex 09
Country [38] 0 0
France
State/province [38] 0 0
Grenoble Cedex
Country [39] 0 0
France
State/province [39] 0 0
La Roche sur Yon Cedex 9
Country [40] 0 0
France
State/province [40] 0 0
Le Chesnay Cedex
Country [41] 0 0
France
State/province [41] 0 0
Le Mans
Country [42] 0 0
France
State/province [42] 0 0
Lille Cedex
Country [43] 0 0
France
State/province [43] 0 0
Lille
Country [44] 0 0
France
State/province [44] 0 0
Lorient cedex
Country [45] 0 0
France
State/province [45] 0 0
Lyon Cedex 08
Country [46] 0 0
France
State/province [46] 0 0
Metz Cedex 03
Country [47] 0 0
France
State/province [47] 0 0
Mont de Marsan
Country [48] 0 0
France
State/province [48] 0 0
Montpellier cedex 5
Country [49] 0 0
France
State/province [49] 0 0
Montpellier
Country [50] 0 0
France
State/province [50] 0 0
Nancy
Country [51] 0 0
France
State/province [51] 0 0
Nantes Cedex 2
Country [52] 0 0
France
State/province [52] 0 0
Nice Cedex 2
Country [53] 0 0
France
State/province [53] 0 0
Nimes
Country [54] 0 0
France
State/province [54] 0 0
Orleans
Country [55] 0 0
France
State/province [55] 0 0
Paris cedex 05
Country [56] 0 0
France
State/province [56] 0 0
Paris Cedex 10
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This was a study to determine whether therapy with pazopanib was effective and safe in women
with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not
progressed on first line chemotherapy.
Trial website
https://clinicaltrials.gov/show/NCT00866697
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications